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Report

Review of the HIVNET 012 Perinatal HIV Prevention Study

Released:
April 7, 2005
Type:
Consensus Report
Topics:
Biomedical and Health Research, Public Health
Activity:
Reviewing the HIVNET 012 Clinical Trial
Board:
Board on Population Health and Public Health Practice

Previous evaluations of HIVNET 012, a 1997 study of AIDS medication conducted in Uganda, left lingering uncertainties about the trial's results, suggesting the need for a definitive, independent review.  The HIVNET 012 trial was a randomized, controlled study that compared the safety and efficacy of two short-course regimens of antiviral drugs, nevirapine and zidovudine, in preventing transmission of HIV from HIV-infected mothers to their infants. 

The Institute of Medicine's new and independent analysis focused on the scientific validity of the study's conclusions based on a close examination of how researchers from Johns Hopkins University and Uganda's Makerere University conducted the trial.  The IOM's review of HIVNET 012 was requested and funded by the National Institutes of Health, which also funded the original trial in Uganda.

This report concludes that the Ugandan drug trial's findings that the AIDS medication nevirapine is effective and safe in preventing HIV transmission from mother to unborn child during birth were well-supported.  The IOM's analysis of the design and methodology of the HIVNET 012 determined that policy-makers and other scientists can rely on the resulting data and conclusions.


 


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